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FDA approves Adcetris for primary cutaneous anaplastic large cell lymphoma
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The FDA today approved brentuximab vedotin for the treatment of primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides in adult patients who have received prior systemic therapy.
The agency based the approval on data from the randomized phase 3 ALCANZA trial, designed to compare brentuximab vedotin (Adcetris, Seattle Genetics) — an antibody-drug conjugate directed to CD30 — with standard therapies among 131 patients with cutaneous T-cell lymphoma that required systemic therapy.
“Our phase 3 ALCANZA clinical trial ... demonstrated superior efficacy with durable responses for long-term disease management when compared [with] standard-of-care treatment options methotrexate and bexarotene,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a press release. “This FDA approval, which was granted more than a month in advance of the [Prescription Drug User Fee Act] date, represents a significant milestone for the lymphoma community.”
In the trial, researchers randomly assigned patients to receive brentuximab vedotin or the physician’s choice of methotrexate or bexarotene. Objective response that lasted at least 4 months (ORR4) served as the primary endpoint. Secondary endpoints included complete response rate, PFS and reduction in symptom burden.
A higher percentage of patients treated with brentuximab vedotin achieved ORR4 (56.3% vs. 12.5%; P < .0001). Patients in the brentuximab vedotin arm demonstrated a superior complete response rate compared with the physician’s choice arm (16% vs. 2%; P = .007).
Researchers also observed a significant improvement in PFS with brentuximab vedotin (median PFS, 17 months vs. 4 months; estimated HR = 0.27; 95% CI, 0.17-0.43).
The most common adverse events related to brentuximab vedotin included anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia. The most common adverse event that led to treatment discontinuation was peripheral neuropathy.
The recommended dose of brentuximab vedotin is 1.8 mg/kg up to a maximum of 180 mg via intravenous infusion over 30 minutes every 3 weeks until a maximum of 16 cycles, disease progression or unacceptable toxicity.
“As both a patient and representative of the cutaneous lymphoma community, we welcome the FDA approval of Adcetris as a new treatment option for the most common subtypes of cutaneous T-cell lymphoma [among] patients who require systemic therapy and we look forward to sharing this important milestone with patients and physicians,” Susan Thornton, CEO of the Cutaneous Lymphoma Foundation, said in the release.
The FDA granted priority review to brentuximab vedotin for the treatment of cutaneous T-cell lymphoma in August.